1 Department of Radiology, University Hospital, LMU Munich, Munich, Germany. Electronic address: email@example.com.
2 Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
3 Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany.
4 Department of Interventional Radiology, Pisa University Hospitalvia Paradisa 2, 56100 Pisa, Italy.
5 Department of Nuclear Medicine, University Hospital, LMU Munich, Munich, Germany.
6 Department of Medicine II, Liver Center Munich, University Hospital, Munich, Germany.
7 Internal Medicine, Gastroenterology and Hepatic Diseases Unit, IRCCS Fondazione Policlinico Universitario A. Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
8 Department of Radiology and Nuclear Medicine, University of Magdeburg, Leipziger Str.44, 39120, Magdeburg, Germany.
9 Department of Internal Medicine and Gastroenterology, Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria.
10 Clinical Institute of Radiology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
11 APHP, Hôpital La Pitié Salpêtrière, Service d'Hépato-Gastroentérologie, Paris, France.
12 Department of Gastroenterology, Hepatology and Diabetology, Internal Medicine II, HELIOS Hospital Emil von Behring, Berlin, Germany.
13 University Hospital, LMU Munich, Munich, Germany.
14 Department of Digestive Oncology, University Hospital Leuven, Leuven, Belgium.
15 Liver Unit, Clinica Universidad de Navarra-IDISNA and CIBEREHD, Pamplona, Spain.
16 Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.
Sorafenib is the recommended treatment for patients with advanced hepatocellular carcinoma (HCC). We aimed to compare the efficacy and safety of a combination of selective internal radiotherapy (SIRT) with yttrium-90 (90Y) resin microspheres and sorafenib with those of sorafenib alone in patients with advanced HCC.
SORAMIC is a randomised controlled trial comprising diagnostic, local ablation and palliative cohorts. Based on diagnostic study results patients were assigned to local ablation or palliative cohorts. In the palliative cohort, patients not eligible for TACE were randomised 11:10 to SIRT plus sorafenib (SIRT+sorafenib) or sorafenib alone. The primary endpoint was overall survival (OS; Kaplan-Meier analysis) in the intention-to-treat (ITT) population.
In the ITT cohort, 216 patients were randomised to SIRT+sorafenib and 208 to sorafenib alone. Median OS was 12·1 months in the SIRT+sorafenib arm, and 11·4months in the sorafenib arm (hazard ratio [HR], 1·01; 95% CI 0·81-1·25; p=0·9529). Median OS in the per-protocol population, was 14·0 months in the SIRT+sorafenib arm (n=114), and 11·1months in the sorafenib arm (n=174; HR, 0·86; p=0·2515). Subgroup analyses of the PP population indicated a survival benefit of SIRT+sorafenib for patients without cirrhosis (HR, 0·46, 0·25-0·86; p=0·02); cirrhosis of non-alcoholic aetiology (HR, 0·63, p=0·012); or patients ≤65 years (HR, 0·65, p=0·05). Adverse events (AEs) of Common Terminology Criteria for AE Grades 3-4 were reported in 103/159 (64·8%) patients who received SIRT+sorafenib, 106/197 (53·8%) patients who received sorafenib only (p=0·04), and 8/24 (33·3%) patients who only received SIRT.
Addition of SIRT to sorafenib did not result in a significant improvement in OS compared with sorafenib alone. Subgroup analyses led to hypothesis-generating results supporting future study design. Funding Financial support by Sirtex Medical and Bayer Healthcare Lay summary Sorafenib given orally is the recommended treatment for patients with advanced hepatocellular carcinoma (HCC). In selective internal radiotherapy therapy (SIRT), also known as radioembolisation, microscopic, radioactive resin or glass spheres are introduced into the blood vessels that feed the tumours in the liver. This study found that the addition of SIRT with 90yttrium-loaded resin microspheres to sorafenib treatment in people with advanced HCC did not significantly improve overall survival compared with sorafenib treatment alone. However, the results suggest how future studies on this combination therapy in people with advanced HCC could be designed.